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Home » Newsletters » BioWorld

BioWorld

May 23, 2018

View Archived Issues

Regulatory front

A federal jury in Manhattan Tuesday found Gary Tanner, a former executive at Valeant Pharmaceuticals International Inc., and Andrew Davenport, the former CEO of Philidor Rx Services LLC, guilty of fraud and conspiracy. The two men were each charged in November 2016 with four counts, including wire fraud and conspiracy to commit money laundering, stemming from what the U.S. Department of Justice (DoJ) called "a multimillion-dollar fraud and kickback scheme."  Read More

Financings

Melinta Therapeutics Inc., of New Haven, Conn., said it has begun an underwritten public offering of shares of its common stock to raise aggregate proceeds of approximately $75 million. The company intends to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares on the same terms and conditions. The net proceeds will be used for general corporate purposes, including investing in its portfolio of antibiotics. Read More

Other news to note

Clinigen Group plc, of Burton-on-Trent, U.K., said it partnered with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, to initiate a managed access program (also known as an early access program) in Europe for edaravone, an intravenous treatment for amyotrophic lateral sclerosis. Edaravone, an intravenously administered antioxidant free radical scavengers, is approved in Japan, South Korea and the U.S.  Read More

Clinical data for May 22, 2018

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Longeveron testing cell therapy as flu vaccine booster

Longeveron LLC, a Miami-based company developing allogeneic mesenchymal stem cell therapies (MSCs) for aging-related conditions, has landed a $750,000 grant from the Maryland Technology Development Corp. to support an ongoing trial examining the safety and efficacy of its bone-marrow-sourced cells to improve flu vaccine immune-response in elderly patients with aging frailty. Read More

Senate take on right to try is headed for the law books

A "beacon of hope" won out Tuesday over fears of snake oil salesmen and the Martin Shkrelis of the world as the House voted 250-169 to give patients with a life-threatening illness the right to try an experimental drug or device. Read More

Schizophrenia goes from risk genes to risk cells

Scientists from the Major Depressive Disorder Working Group of the Psychiatric Genomics Consortium and the Karolinska Institutet have mapped the effects of schizophrenia risk variants to a few specific cell types. Knowledge of the risk variants themselves has not yet led to obvious new targets for the disorder, in part because of the brain's large number of cell types. Read More

Sublimity's colon-targeted cyclosporine advancing in UC with $64M round

Despite the rise of biologics – and biosimilars – in the ulcerative colitis (UC) space, investors backed Dublin-based Sublimity Therapeutics Ltd. in a $64 million round to advance STI-0529, its orally delivered soluble version of cyclosporine, into a phase IIb study. Read More

Endocyte wows with late, early stage cancer efforts targeting prostate, bone

The phrase "game changer" in the context of prostate cancer seems like a bold claim, but at least one analyst sees that degree of potential for one of Endocyte Inc.'s pipeline candidates. But first, consider the West Lafayette, Ind.-based firm's chimeric antigen receptor T-cell (CAR T) effort, which drew attention at the American Association for Cancer Research (AACR) meeting last month in Chicago. Read More

Allergan bulks up on NMDAs as depression landscape starts to shift

Allergan plc exercised its option to acquire AGN-241751, an oral small-molecule N-methyl-D-aspartate (NMDA) receptor modulator that was discovered by Aptinyx Inc. and advanced under an ongoing research collaboration between the companies. Allergan gained option rights to certain small molecules from the Aptinyx discovery platform under a research collaboration initiated in conjunction with its 2015 acquisition of Naurex Inc., which simultaneously spun out Aptinyx and its platform. As part of that transaction, Allergan also acquired rapastinel, an intravenously administered NMDA receptor modulating tetrapeptide that subsequently received breakthrough therapy designation from the FDA and has advanced to phase III development in major depressive disorder (MDD). (See BioWorld Today, Sept. 16, 2015.) Read More

Regulatory actions for May 22, 2018

Read More

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